Abstract. Background: There is no consensus on the need for adjuvant chemotherapy for patients with pathological residual invasive breast cancer (non-pCR) after neoadjuvant chemotherapy (NAC). We evaluated the tolerability and safety of tegafur-uracil (UFT) as adjuvant chemotherapy for patients with human epidermal growth factor receptor 2-negative breast cancer that resulted in non-pCR after NAC. Patients and MethodsNeoadjuvant chemotherapy (NAC) is widely used for both locally advanced and early-stage breast cancer. The advantages of NAC include determining tumor responses to specific treatment regimens in clinical practice and providing an opportunity for down-staging to avoid mastectomy for inoperable tumors or breast-conserving surgery in cases originally requiring mastectomy (1, 2). Anthracyclines and taxanes have been used as the standard chemotherapeutic regimens for breast cancer, however, tumoral estrogen receptor (ER) and human epidermal growth factor receptor 2 (HER2) statuses are important predictors of response to chemotherapy (3)(4)(5). Sensitivity to NAC is lower in ERpositive and HER2-negative cancer than in other subtypes. An earlier study of NAC with anthracyclines and taxanes reported an approximately 25% pathological complete response (pCR) rate in cases of operable breast cancer without taking in mind the ER and HER2 status (6). Furthermore, patients achieving pCR have a more favorable prognosis than patients with pathological residual invasive disease (non-pCR) (6-8). Adjuvant endocrine therapy for ERpositive breast cancer and anti-HER2 therapy (e.g. Trastuzumab) for HER2-positive breast cancer after NAC currently represent the gold-standard of care. There is a lack of consensus regarding the requirement for an adjuvant chemotherapy in cases with non-pCR after NAC; however, further chemotherapy may improve patient outcomes. Adjuvant chemotherapy is typically appropriate in patients with non-pCR because patients with operable breast cancer frequently experience tumor recurrence approximately 2 years after initial surgery (9).Long-term, daily oral treatment with tegafur-uracil (UFT) is widely used as an adjuvant chemotherapy for breast, gastric, and colorectal cancer in Japan. (10). A pooled analysis of six randomized, controlled trials demonstrated the survival benefits of adjuvant UFT plus tamoxifen compared to tamoxifen alone for ER-positive early breast cancer (11). Moreover, two randomized, controlled trials demonstrated that UFT therapy for 2 years had similar efficacy to six cycles of cyclophosphamide, methotrexate, and 5-fluorouracil (CMF) 6505Τhis article is freely accessible online. 10, 12). However, the safety of UFT therapy in patients previously treated with NAC remains unknown. Therefore, we evaluated the tolerability and safety of adjuvant UFT chemotherapy for 2 years in patients with HER2-negative breast cancer with non-pCR after standard anthracycline-and taxane-based NAC to assess the preliminary efficacy of UFT therapy. Patients and MethodsThis present study was conducted...

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e12594 Background: Anthracycline and Taxane have been widely used and studied in neoadjuvant setting for treatment of locally advanced breast cancer. Various regimens have explored the addition of newer agents to determine safety and efficacy, and pathological complete response(pCR) has been demonstrated to be associated with favorable overall survival in primary breast cancer. Pertuzumab increases the rate of pathological complete response in the preoperative context and increases overall survival among patients with metastatic disease when it is added to Trastuzumab and chemotherapy for the treatment of human epidermal growth factor receptor 2 (Her2)-positive breast cancer. In addition, APHINITY trial showed that Pertuzumab significantly improved the rates of invasive-disease-free survival among patients with HER2-positive, operable breast cancer when it was added to Tastuzumab and chemotherapy. We conducted a clinical phase II neoadjuvant trial of nab-Paclitaxel, Trastuzumab and Pertuzumab followed by Anthracycline Based Regimens in Patients with Operable Her2 Positive Breast Cancer. Methods: The study is designed to evaluate nab-paclitaxel, Trastuzumab and Pertuzumab followed by EC or AC or FEC as neoadjuvant therapy in patients with Her2 positive operable breast cancer. Patients are treated with neoadjuvant nab-paclitaxel(260 mg/m2 ), Trastuzumab and Pertuzumab followed by EC(Epirubicin 90 mg/m2 , Cyclophosphamide 600 mg/m2) or AC(Doxorubicin 60 mg/m2 , Cyclophosphamide 600 mg/m2) or FEC(Fluorouracil 500mg/m2, Epirubicin 100 mg/m2 , Cyclophosphamide 500 mg/m2 ) q21d x 4. Patients undergo surgery 4-6 weeks later from completing chemotherapy. The primary endpoint, pCR is defined as no evidence of invasive tumors in the final surgical sample both in the breast and axillary lymph nodes. Secondary endpoints include overall response rate, disease-free survival, rate of breast conserving surgery, histological response rate, rate of sensory neuropathy ant the safety of the treatment. Results: In 30 evaluable patients, the pCR rate was 50%; 6/19 (31.6%) in ER-positive and 9/11 (81.8%) in ER-negative, 1/7 (14.3%) in IHC 2+, FISH positive and 14/23 (60.9%) in IHC 3+ . Of the study treatments, the most frequent reason for delay or dose reduction was hematologic toxicity; no patient required a dose reduction for nab-PTX because of peripheral neuropathy. Conclusions: Neoadjuvant treatment using albumin-bound Paclitaxel, Trastuzumab and Pertuzumab followed by Anthracycline based regimens appears to be effective especially in pure HER2 type or IHC 3+ cases.